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Biohazardous Returns Processing

Most medical device companies have product returns which are biohazardous. Some of these returns are biohazardous because hospitals didn’t follow their internal procedures, some are products that would have been disposed off by the hospital, but due to an issue in surgery they must be returned to the manufacturer, and some products are intended for reuse but must go through

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Quality Systems and Medical Device Incubators go hand-in-hand

There has been an increase in the number of start-up med device companies joining, or being founded in conjunction with, Incubators. Medical Device Incubators have traditionally catered more to the business plan development or product research/design aspects of the business. And in most cases these incubators require an equity stake in the company in return for their services

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Distribution Simulation Testing, ASTM D4169 & ISTA

Distribution Simulation Testing assesses a medical package’s ability to protect and maintain sterility of the products within.  This is accomplished by exposing the package to real-life hazardous conditions that it could face through the handling, distribution and storage stages of its journey.   The package/container and its contents are subjected to a test plan involving shock, […]

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